Pathnostics COVID-19 PCR Test

You will receive the test results from Pathnostics within 24-48 hours from the time of receipt at the laboratory.

Pathnostics will report the test results to the state health department and the ordering authorized provider.

The Pathnostics COVID19 test seeks to detect three different SARS-CoV-2 genes (ORF1ab, N gene, and S gene). The COVID-19 test results as positive when a signal is obtained from two or more SARS-CoV-2 targets. If a signal is obtained from only one of the three targets, the test is repeated. If the repeat result is the same, the results would be reported as ‘Inconclusive’. We would expect to see an ‘Inconclusive’ result rarely if at all, as the sequences targeted by the assay are conserved and highly specific to this virus.

Medicare, Medicaid and private payers will cover the full cost of COVID-19 testing if the test is medically necessary and ordered by a qualified healthcare professional.

Pathnostics will cover the cost of shipping the samples to you and also back to us.

• PCR detects the genetic information of the virus.  That’s only possible if the virus is there and someone is actively infected.
• The COVID-19 PCR Test is a sensitive molecular test that targets the detection of three SARS-CoV 2 genes and provides information as to those patients that are currently infectious.
• PCR test results give a good indication of who is infected.  This is information that can break the transmission chain of the virus.

The diagnostic sensitivity of the Pathnostics COVID-19 test was determined to be 100% in detecting known amounts of SARS-Cov-2 RNA. A negative result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection of the assay (10 copies of SARS-CoV-2 RNA, equal to the limit of detection of the EUA Thermo Fisher TaqPath COVID-19 Combo kit).Detection depends upon proper sample collection and the spread of the virus to the collection site; a negative result does not rule out COVID-19 as it could be present below the limit of detection and is therefore reported as “Not Detected” instead of “Negative”. A “Not Detected” result should not be used as the sole basis for treatment or patient management decisions according to CDC guidelines. In general, it is believed that nasal swabs (nasopharyngeal, mid-turbinate, anterior nares) method of collection in conjunction with PCR testing reliably detects 70-80% of true COVID-19 positive cases.

The Pathnostics COVID-19 PCR test is a Laboratory Developed Test (LDT) employing real-time PCR (RT-PCR) for the molecular detection of SARS-CoV-2 RNA and has been modified from the Thermo Fisher Scientific, Inc. Taqpath COVID-19 Combo Kit that was authorized for Emergency Use on 3/13/2020. As referenced in the FDA “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency”, a laboratory certified under Clinical Laboratory Improvement Amendments (CLIA) that meets the CLIA regulatory requirements to perform high complexity testing may use their LDT test without a new or amended EUA where the test is validated using a bridging study to an EUA-authorized test. Pathnostics is a CLIA laboratory authorized to perform high complexity testing and the Pathnostics COVID-19 PCR test has been validated with a bridging study to the EUA TaqPath COVID-19 Combo Kit.